WO2022240742A1 - Dispositif semi-rigide pour fixation orthopédique - Google Patents

Dispositif semi-rigide pour fixation orthopédique Download PDF

Info

Publication number
WO2022240742A1
WO2022240742A1 PCT/US2022/028325 US2022028325W WO2022240742A1 WO 2022240742 A1 WO2022240742 A1 WO 2022240742A1 US 2022028325 W US2022028325 W US 2022028325W WO 2022240742 A1 WO2022240742 A1 WO 2022240742A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone
rigid
flexible member
fixation device
anchor portion
Prior art date
Application number
PCT/US2022/028325
Other languages
English (en)
Inventor
Tyler Joseph TOUCHET
Jon Olson
Original Assignee
Trilliant Surgical Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Trilliant Surgical Llc filed Critical Trilliant Surgical Llc
Priority to EP22726892.7A priority Critical patent/EP4337118A1/fr
Publication of WO2022240742A1 publication Critical patent/WO2022240742A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/683—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/8635—Tips of screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8605—Heads, i.e. proximal ends projecting from bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/863—Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
    • A61B2017/0443—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws the shaft being resilient and having a coiled or helical shape in the released state
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0445—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors cannulated, e.g. with a longitudinal through-hole for passage of an instrument

Definitions

  • the disclosure relates to semi-rigid devices for orthopedic fixation. More specifically, the disclosure relates to semi-rigid fixation devices having two substantially rigid members coupled to one another via a flexible member, the flexible member coupled to a respective one of the substantially rigid members at each end. Methods of using and/or manufacturing such semi-rigid fixation devices are likewise provided.
  • a syndesmosis is a type of joint. More specifically, a syndesmosis is a movable articulation where contiguous bony surfaces are united by an interosseous ligament. An example is the inferior tibiofibular articulation of the ankle. This syndesmosis is made up of the anterior tibiofibular ligament, the interosseous ligament, and the posterior-fibular ligaments. Following trauma to the ankle, such as an ankle fracture, the syndesmotic joint can become unstable and painful.
  • Syndesmosis injury can also occur without fracture, such as with a severe ankle sprain.
  • An example of this type of syndesmosis injury is torn ligaments without any bone fracture. Surgery may be needed to stabilize the syndesmotic joint to allow these ligaments to properly heal.
  • Various injuries include separation of soft tissue from one or more bones and/or separation of bones from normally anatomical correct positioning. Maintaining the bones in the correct anatomical positions during healing is important to provide proper soft tissue reattachment and proper bone healing.
  • the current standard of care involves fixing the fibula to the tibia during the soft tissue healing process with one or two screws that are continuously rigid along their lengths of extent. Because these screws can inhibit normal joint motion, the screws are typically removed after the ligament injury is healed.
  • syndesmosis repair systems and methods rely on such continuously rigid screws for coupling the tibia and the fibular and replacing the syndesmosis. These continuously rigid screws inhibit normal movement and articulation of the bones, for example, the tibia and fibula, and further limit one or more corresponding joints.
  • a semi-rigid fixation device for orthopedic fixation includes a rigid anchor portion configured to be directly rotated and driven distally into a first bone or bone portion of a patient.
  • the device includes a rigid cap portion configured to be held in tension against at least one of a bone plate and a second bone or bone portion of the patient and indirectly rotated under a torque provided by the rigid anchor portion.
  • the device includes a flexible member comprising a plurality of woven stands.
  • the flexible member has a fixed length between a first end and a second end. The first end is fixedly coupled to the rigid anchor portion. The second end is fixedly coupled to the rigid cap portion such that a torque provided by the direct rotation of the rigid anchor portion is transferred through the flexible member to the rigid cap when the flexible member is held in at least a first amount of longitudinal tension.
  • a method of using a semi-rigid fixation device for orthopedic fixation of a bone includes directly rotating a rigid anchor portion of a fixation device, thereby driving the rigid anchor portion distally into a first bone or bone portion of a patient.
  • the rigid anchor portion is fixedly coupled to a first end of a flexible member that includes a plurality of woven strands and has a fixed length.
  • a second end of the flexible member is fixedly coupled to a rigid cap portion.
  • the method includes causing the rigid cap portion to be indirectly rotated under a torque provided by the rigid anchor portion and transferred through the flexible member when the rigid cap portion is held in at least a first amount of longitudinal tension against at least one of a bone plate and a second bone or bone portion of the patient.
  • a method of manufacturing a semi-rigid fixation device for orthopedic fixation of a bone includes providing a flexible member that includes a plurality of woven stands and has a fixed length. The method includes fixedly coupling a first end of the flexible member to a rigid anchor portion that is configured to be directly rotated and driven distally into a first bone or bone portion of a patient. The method includes fixedly coupling a second end of the flexible member to a rigid cap portion that is configured to be indirectly rotated under a torque provided by the rigid anchor portion and transferred through the flexible member when the rigid cap portion is held in at least a first amount of longitudinal tension against at least one of a bone plate and a second bone or bone portion of the patient.
  • FIG. 1 is a side view of a fixation device, according to some example embodiments;
  • FIG. 2 is a perspective view of the fixation device of FIG. 1 ;
  • FIG. 3 is a side view of a fixation device, according to some example embodiments.
  • FIG. 4 is a side view of a fixation device, according to some other example embodiments.
  • FIG. 5 is a side view of a fixation device, according to yet other example embodiments.
  • FIG. 6 is a side view of a fixation device, according to yet other example embodiments.
  • FIG. 7 illustrates a woven tube portion of a fixation device, according to some example embodiments.
  • FIG. 8 illustrates a woven tube portion of a fixation device, according to some other example embodiments.
  • FIG. 9 illustrates a fixation device disposed at least partially within a tibia and a fibula of a patient, according to some embodiments
  • FIG. 10 illustrates a flowchart related to a method of using a fixation device, according to some example embodiments.
  • FIG. 11 illustrates a flowchart related to a method of manufacturing a fixation device, according to some example embodiments.
  • Implementations of the technology described herein are directed generally to a semi-rigid device for orthopedic fixation.
  • proximal and distal denote a relative location or orientation of a particular feature with respect to other potential locations and/or orientations for that feature with respect to some reference. Often this reference may be with respect to a direction of extension or with respect to a practitioner.
  • the proximal end of fixation devices described herein corresponds to the end nearest the cap portion and the distal end corresponds to the opposite end, along the longitudinal length of extension 150 (see, e.g., FIG. 1).
  • proximal and distal may also reference the relative side, end or surface of a particular feature of with the same correspondence to and along the longitudinal length of extension 150.
  • the disclosure relates to a fixed-length flexible fixation device that does not rely on additional tensioning steps, sutures, laser-cut, or flexible metallic components.
  • the device can be used where semi-rigid fixation is needed (i.e., syndesmotic repair).
  • semi-rigid fixation i.e., syndesmotic repair.
  • two substantially cylindrical components may be attached inline with a third intermediate component that provides anchored fixation to bone and/or soft tissue.
  • tension and degree of fixation are determined by the insertion depth of the third component.
  • Such exemplary implementations, embodiments, and arrangements provide the benefits of both a solid fixation for tension or axial load while providing movement or translation laterally. This is especially important in the primary target application of syndesmotic joint repair.
  • the syndesmotic joint is an effective joint that stabilizes the motion between the fibula and tibia at the interface with the talus. Mobility is maintained by the slight motion allowed.
  • FIGs. 1 and 3 illustrate side views, while FIG. 2 illustrates a perspective view of a fixation device 100, according to some example embodiments.
  • Fixation device 100 comprises an anchor portion 110, a cap portion 120, and a flexible member 130.
  • anchor portion 110 and cap portion 120 are each rigid.
  • cap portion 120, flexible portion 130, and anchor portion 110 each have a respective length Li, l_2 and l_3.
  • the length Li of cap portion 120 may be related to, slightly longer than, slightly shorter than or substantially equal to a width of a fibula (e.g., fibula 910 in FIG.
  • l_20f flexible member 130 may be chosen based on a typical anatomically correct spacing or actual anatomically correct spacing between a fibula and tibia of a patient in which fixation device 100 is to be implanted. Such a length l_2 of flexible member 130 may also take into consideration the torsional rigidity qualities of varying woven or total lengths of flexible member 130. In some but not all embodiments, l_2 may be within the range of 5-25mm.
  • anchor portion 110 may have a length l_3 determined with a capacity for distal advancement and tensioning of flexible member 130 as a result of such distal advancement relative to cap portion 120, as will be described in more detail below. In some but not all embodiments, l_3 may be within the range of 8-40mm.
  • anchor portion 110, flexible member 130, and cap portion 120 are coupled in-line with one another such that a longitudinal axis of extension 150 through a center of fixation device 100 is coincident with individual longitudinal axes through respective centers of each of anchor portion 110, flexible member 130, and cap portion 120. Such axial alignment through each component’s center may contribute to one or more advantages of any fixation device disclosed herein, as will be discussed in more detail below.
  • Anchor portion 110 and/or cap portion 120 may comprise any suitable biocompatible metal or polymer such as Ti-6AI-4V, PEEK, polyester, polyamide, polyurethane, polyethylene, ultra-high molecular weight polyethylene (UHMWPE) or combinations thereof.
  • suitable biocompatible metal or polymer such as Ti-6AI-4V, PEEK, polyester, polyamide, polyurethane, polyethylene, ultra-high molecular weight polyethylene (UHMWPE) or combinations thereof.
  • Anchor portion 110 comprises a distal end configured to be driven or otherwise inserted or into bone of a patient, and a proximal end configured to receive a first end of flexible member 130. As illustrated, anchor portion 110 tapers from its proximal end to its distal end. Accordingly, anchor portion 110 may have a substantially conical form that tapers linearly and/or a substantially convex and/or concave conical shape that tapers non-linearly. As illustrated in FIG. 1 , anchor portion 110 may comprise threads 112 configured to bite into the bone of the patient and, thereby contribute to fixation of anchor 110 therein. However, the present disclosure is not so limited and any other suitable method of anchoring is also contemplated.
  • anchor portion 110 contributes to a fixation solution, at least in part, by simultaneously providing a fixation component, a tension component, and a torque component to fixation device 100.
  • the proximal end of anchor portion 110 comprises an aperture 116 configured to receive a tool that is configured to impart a torque directly to anchor portion 110.
  • a shape of at least a distal portion of aperture 116 may be complementary to a shape of a terminal end of such a tool, thereby allowing the tool to be releasably engaged with anchor portion 110, through cap portion 120 and flexible member 130.
  • anchor portion 110 may comprise one or more holes or apertures 114 bored through its side and into aperture 116. Holes 114 may be utilized to tie or otherwise fix an end or immediately adjacent end portion of flexible member 130 to anchor portion 110.
  • Fixation devices utilizing alternatively-configured anchor portions are also contemplated. For example, see FIG. 6 and related discussion below.
  • Cap portion 120 may have a substantially cylindrical form. Cap portion comprises a distal end configured to receive a second end of flexible member 130. In some embodiments, a proximal end of cap portion 120 comprises a lip or rim 122. For example, lip or rim 122 may have a diameter D2 that is greater than a diameter Di of immediately adjacent, joining surfaces of cap portion 120. In some embodiments, D1 may be approximately 4 millimeters (mm). However, the present disclosure is not so limited and Di may have any suitable value.
  • a distal surface of rim 122 may be substantially perpendicular or normal to the adjoining, adjacent surface of cap portion 120. In some other embodiments, the distal surface of rim 122 may intersect the adjoining, adjacent surface of cap portion 120 at an angle (e.g., be beveled) or may curve to provide a smooth transition from the distal surface of rim 122 to the adjoining, adjacent surface of cap portion 120. At least a portion of the distal surface of rim 122 is configured to abut or directly contact at least one of a bone plate (see, e.g., bone plate 900 in FIG. 9), other rigid body, or a bone of a patient as anchor portion 110 is driven into bone of the patient.
  • a bone plate see, e.g., bone plate 900 in FIG. 9
  • an aperture 124 extends entirely through cap portion 120 and has a diameter D3 smaller than the diameter Di but sufficiently large to allow the terminal end of the tool described in connection with anchor portion 110 to extend completely through cap portion 120, completely through flexible portion 130, and into aperture 116 of anchor portion 110.
  • anchor portion 110 rotates and advances distally into the bone as teeth 112 bite into the bone.
  • This distal advancement of anchor portion 110 imparts a longitudinal tension substantially along axis 150 (see, e.g., FIG. 1) that pulls the distal surface of rim 122 into this bone plate, other rigid body, or bone.
  • An amount of friction between at least the distal surface of rim 122 of cap portion 120 and bone plate 900, other rigid body, and/or bone of the patient is proportional to the coefficient of static or sliding friction therebetween (depending on whether cap portion 120 is stationary or rotating, respectively) and proportional to the magnitude of the axial tension imparted tangent (or normal) to mutually-contacting surfaces thereof.
  • the amount of torque imparted to cap portion 120, which flexible member 130 transfers from anchor portion 110 depends on the torque imparted by tool on anchor portion 110 to rotate and distally advance anchor portion 110 into the bone.
  • cap portion 120 and anchor portion 110 illustrated in FIGs. 1 -3 may comprise a locking feature or interface configured to releasably lock with the above described the bone plate, other rigid body, and/or bone of the patient.
  • a locking feature may be one or more grooves and/or protrusions configured to interlock.
  • FIG. 4 illustrates a fixation device 400 comprising anchor portion 110 and flexible member 130 as described herein, but substituting cap portion 420 in place of cap portion 120 of FIGs. 1-3.
  • cap portion 420 comprises threads 422, which may be substantially similar or identical to threads 112 of anchor portion 110. Accordingly, threads 422 are configured to bite into or engage with at least one of bone plate 900, other rigid body, and/or bone of the patient bone as described herein.
  • cap 420 may also comprise rim 122, as previously described in connection with FIG. 1 , at its proximal end.
  • FIG. 5 illustrates a fixation device 500 comprising anchor portion 110 and flexible member 130 as described herein, but substituting cap portion 520 in place of cap 120 of FIGs. 1 -3.
  • cap 420 comprises one or more circumferential or partially-circumferential blades 522 configured to allow friction-fit seating of cap 420 into at least one of the bone plate, other rigid body, and/or bone (e.g., cortical bone) of the patient.
  • blades 522 are sufficiently flexible to allow sufficient deformation in a first direction or sense as cap portion 520 is rotated and pulled distally into the seated position bone.
  • blades 522 are formed to resist symmetrical deformation in a second direction or sense that is opposite to the first direction or sense, e.g., having a distal surface that is beveled or sloped with respect to axis 150 and a proximal surface that is substantially perpendicular to axis 150.
  • blades 522 are formed to theoretically allow symmetrical deformation in a second direction or sense that is opposite to the first direction or sense, e.g., having substantially symmetrically oriented proximal and distal surfaces, but such that this deformation is resisted by the restricted space in which blades 522 are disposed when cap portion 520 is seated within at least one of bone plate 900, other rigid body, and/or bone of the patient bone as described herein. While not illustrated in FIG. 5, cap 520 may also comprise rim 122, as previously described in connection with FIG. 1 , at its proximal end.
  • FIG. 6 illustrates a fixation device 600 comprising cap portion 120 and flexible member 130 as described anywhere herein, but substituting anchor portion 610 in place of anchor portion 110.
  • Anchor portion 610 may be substantially as previously described for anchor portion 110 but omitting all (shown) or at least a proximal, medial or distal portion of threads 112 and including one or more blades 612 disposed in place of omitted threads 112.
  • Blades 612 may be substantially the same as blades 512 of FIG. 5, however, being configured to releasably engage or seat against deeper or different bone, being on more distal anchor portion 610 instead of more proximal cap portion 520.
  • an anchor portion comprising any combination of a substantially smooth side wall, at least a portion of threads 112, and/or blades 612 may be coupled with a cap portion comprising any combination of a substantially smooth side wall, threads 422, and/or blades 522.
  • FIGs. 7 and 8 illustrate example embodiments of flexible member 130, as discussed or illustrated anywhere in this disclosure.
  • a “suture” is defined as “a stitch or row of stitches holding together the edges of two or more features,” for example, a respective end or immediately adjacent end portion of flexible member 130 and either an anchor portion (e.g., 110, 610) or a cap portion (e.g., 120, 420, 520).
  • a “braid” or “braided” feature is defined as “a length comprising 3 or more interlaced strands, where each interlaced strand follows a substantially same path of extension in common with the entire braid (or braided feature).”
  • a “weave” or “woven” feature is defined as “a plurality of threads passing in a first relative direction interlaced with a different plurality of threads passing in a second relative direction that is substantially different than the first relative direction.” For example, interlacing at right angles (90°) generally results in an undistorted weave comprising square or rectangular features formed by the interlaced strands, while interlacing at complementary acute and obtuse angles generally results in an undistorted weave of parallelograms having two of those acute angles and two of those obtuse angles.
  • first relative direction and second relative direction may be interpreted at each common point of contact or interlacing between two or more threads.
  • two individual threads need not each extend in a single, non-changing direction along Its entire length, so long as two such threads extend directly to or from their common point of contact or interlacing in substantially different first and second directions. Accordingly, individual threads may zig-zag between relative directions so long as the threads they interlace with zig-zag in complementary directions.
  • FIGs. 7 and 8 illustrate a weave substantially comprising the above-described square or rectangular pattern.
  • FIG. 7 shows flexible member 130 comprising threads weaved to form a substantially cylindrical tube, as shown at the upper right of FIG. 7. This cylindrical tube is also visually magnified and flattened as shown at the lower left portion of FIG. 7 to better illustrate the weave.
  • a first plurality of threads 132a, 132b passing in a first relative direction are interlaced with a different plurality of threads 134a, 134b passing in a second relative direction that is substantially different than the first relative direction. In the illustration of FIG. 7, this second relative direction is approximately 90°.
  • the weave pattern extends all the way to the respective ends of flexible member 130.
  • these respective woven ends are fixedly secured to an anchor portion 110, 610 and to a cap portion 120, 420, 520 in a manner that aids in substantially preventing creep or stress relaxation.
  • the respective woven ends of flexible member 130 may be tied, melted and/or potted to an anchor portion 110, 610 and to a cap portion 120, 420, 520.
  • the interface between an end or immediately adjacent end portion of flexible member 130 and an anchor portion or a cap portion may comprise a braided or sutured portion, which in some but not all embodiments, is tied into a knot or crimped and press-fit into the anchor portion or cap portion as described anywhere herein.
  • FIG. 8 shows flexible member 130 substantially as shown in FIG. 7, except that the weave pattern transitions to a sutured pattern, where those strands converge or loop to meet at triangular or sutured ends of flexible member 130.
  • the sutured pattern may extend for a first sub-length L.4 of the predetermined length L2 from a first end of flexible member 130.
  • the sutured pattern may also extend for a second sub-length L5 of the predetermined length Ls from a second end of flexible member 130.
  • these respective sutured ends are fixedly tied, melted and/or potted to an anchor portion 110, 610 and to a cap portion 120, 420, 520.
  • the interface between the sutured ends or immediately adjacent end portions of flexible member 130 and an anchor portion or a cap portion may be braided, which in some but not all embodiments, may be tied into a knot or crimped and press-fit into the anchor portion or cap portion as described anywhere herein.
  • flexible member 130 has a substantially similar diameter to that of mating ends of the anchor portion and the cap portion. Accordingly, in some but not all embodiments, flexible member 130 has a diameter of approximately 4mm. In some but not all embodiments, a thickness of flexible member 130 is approximately 0.5mm. Accordingly, in some but not all such embodiments, the plurality of threads ⁇ e.g., 132, 134) from which flexible member 130 is woven may each have diameters of approximately 0.5mm. However, the present disclosure is not so limited and flexible member 130 and/or its comprised strands may have any suitable thickness(es).
  • the woven, substantially tubular nature of flexible member 130 provides several features that simultaneously contribute to the ability of fixation devices described herein to achieve their intended use(s): creep-resistance (or resistance to slacking of the individual contact points between interlacing strands of the weave over significant durations under relevant tension) and the transformable ability to provide lateral and torsional flexibility when flexible member 130 is not under tension and the different, transformed ability to provide sufficient functional torsional rigidity to efficiently and effectively transmit torque applied at the anchor portion side of flexible member 130 to the cap portion side of flexible member 130 when flexible member 130 is under sufficient axial tension.
  • Example torques flexible member 130 would be expected to be able to effectively transfer may be 150 foot-pounds of torque.
  • the woven nature of flexible member 130 and the coupled anchor and cap portions having the above-described functionalities, work synergistically to provide the emergent properties the described fixation devices as a whole possess, but which are not possessed by any one of their components - specifically the above-described transformable and transformed abilities.
  • an ability of flexible member 130 to effectively transmit sufficient torque is at least partly a function of the ability to restrict relative motion between relatively proximate points of the flexible member 130.
  • these relatively proximate points may be considered points of contact between interlacing strands of the weave.
  • anchor portion 110, 610 is driven directly and advanced distally into bone while cap portion 120, 420, 520 is held longitudinally stationary against at least one of a bone plate (see, e.g., bone plate 900 in FIG. 9), other rigid body, or a bone of the patient, flexible member 130 being fixedly coupled therebetween causes the individual woven strands to act as buttresses to one another, resisting deformation of flexible member 130 as the anchor portion is advanced and as the cap portion is indirectly driven by the transferred torque.
  • a bone plate see, e.g., bone plate 900 in FIG. 9
  • the exemplary implementations, embodiments, and arrangements disclosed herein are based in part on the surprising advantages derived from having a flexible member having a fixed length, woven tubular design in conjunction with attachment of a first end of that flexible member to an anchor portion having a direct interface with a driver tool and attachment of a second end of that flexible member to a cap portion to which the fixation device transmits torque, such that torque is applied directly to the distal, anchor component and does not originate from the proximal, cap component.
  • FIG. 9 illustrates fixation device 110 disposed at least partially within a tibia 920 and a fibula 910 of a patient for syndesmotic repair, according to some embodiments.
  • bone plate 900 is placed against the lateral side of the fibula and a pilot hole (not shown) may be drilled through fibula 910 and into tibia 920.
  • a pilot hole (not shown) may be drilled through fibula 910 and into tibia 920.
  • At least a terminal end of a driving tool may then be inserted through aperture 124 of cap portion 120, through the hollow center of flexible portion 130, to interface in the complementary-shaped aperture 116 of anchor portion 110.
  • Flexible portion 130 may be held in sufficient longitudinal or axial tension by pulling cap portion 120 away from anchor portion 110 as the distal tip of anchor portion 110 is inserted through aperture 902 of bone plate 900 and through the hole in fibula 910 in preparation of driving anchor portion 110 into tibia 920.
  • anchor portion 110 is directly driven to rotate by driver tool and extends distally into tibia 920, the fixed length of flexible membrane 130 goes taut and, as the longitudinal or axial tension builds in flexible membrane 130 so does its rigidity and torque is effectively transmitted through flexible membrane to rotate cap 120.
  • This torque will be relatively small at first, a product of the initially lower longitudinal or axial tension and, also, a consequently lower frictional force between plate 900 and cap portion 120.
  • fixation device 10 fixes fibula 910 in a suitable orientation with tibia 920.
  • Driving tool can be withdrawn from aperture 124 of cap portion 120 and the initial incision closed. In this way, the bones of the lower leg are supported until the ligaments and other soft tissue can heal properly.
  • fixation devices as disclosed herein is that the flexibility of the weave, while readily resisting torsional or twisting/bunching deformation when torque is applied, can still allow a very modest degree of freedom in the “skewing” or “leaning” deformation sense when that torque is no longer applied after implantation. For example, slight lateral (or radial in this case) displacements between the individual longitudinal axes of the cap and anchor portions are accommodated by flexible member 130. This also helps solve problems in current devices such as "suture sawing.”
  • the fixation devices described herein are well-suited for use in syndesmotic repair.
  • the device can also be used in other soft tissue fixation/augmentation orthopedic procedures.
  • the device can be used in the fixation/fusion of osteotomies or fractures to aid in a boney fusion.
  • Embodiments of the fixation devices described herein may passes through two, three or four cortices. Where the fixation device is utilized to stabilize a fracture in, for example, the tibia, passing through or nearly through the tibia only, the fixation device passes through two cortices. Where the fixation device passes completely through the fibula and into the tibia (see, e.g., FIG. 9), the fixation device passes through three - two of the fibula and one the tibia. Where the fixation device passes completely through both the fibula and the tibia (or nearly through the tibia), the fixation device passes through four - two of the fibula and two of the tibia.
  • fixation devices described herein address the issue of the distal nerve impingement common with current solutions.
  • some current solutions use a button and lace system in which a metal strand is anchored to the tibia and looped and pulled through several passes through the fibula and between the tibia and this button. When these laces are cinched up, local nerves are pinched and cause permanent damage.
  • the fixed length of flexible member 130 ensures proper tension is reached during implantation, so the practitioner does not have to perform a secondary tensioning operation.
  • FIG. 10 illustrates a flowchart 1000 related to a method of using a fixation device, according to some example embodiments.
  • Applicable fixation devices include but are not limited to any fixation device as shown, described and/or inferred herein. While certain actions and/or steps are discussed in a particular order, the present disclosure is not so limited and, unless specifically indicated, a method of using a fixation device as discussed anywhere in this disclosure may include one or more additional steps and/or actions, omit one or more disclosed steps and/or actions, or comprise any combination of such steps and/or actions in any suitable order.
  • Flowchart includes block 1002, which includes directly rotating a rigid anchor portion of a fixation device, thereby driving the rigid anchor portion distally into a first bone or bone portion of a patient, wherein the rigid anchor portion is fixedly coupled to a first end of a flexible member, comprising a plurality of woven strands and having a fixed length, and a second end of the flexible member is fixedly coupled to a rigid cap portion.
  • anchor portion 110, 610 of fixation device 100, 600 is configured to be directly rotated by a driving tool as described and/or inferred anywhere in this disclosure, thereby driving anchor portion 110, 610 distally into a first bone or bone portion of a patient (e.g., tibia 920 of FIG.
  • anchor portion 110, 610 is fixedly coupled to a first end of flexible member 130, which includes a plurality of woven strands (e.g., 132a-b, 134a-b) and having a fixed length l_2, and a second end of flexible member 130 is fixedly coupled to cap portion 120, 420, 520.
  • a plurality of woven strands e.g., 132a-b, 134a-b
  • Flowchart includes block 1004, which includes causing the rigid cap portion to be indirectly rotated under a torque provided by the rigid anchor portion and transferred through the flexible member when the rigid cap portion is held in at least a first amount of longitudinal tension against at least one of a bone plate and a second bone or bone portion of the patient.
  • a practician implanting the technology may use the driving tool to directly rotate anchor portion 110, 610, through aperture 124 in cap portion 120, 420, 520 and through the hollow center of flexible member 1130, which causes cap portion 120, 420, 520 to be indirectly rotated under a torque provided by anchor portion 110, 610 and transferred through flexible member 130 when cap portion 120, 420, 520 is held in at least a first amount of longitudinal tension against at least one of bone plate 900 and a second bone or bone portion of the patient (e.g., fibula 910 in FIG. 9).
  • Such a method of use may include any other suitable step or action for implanting any fixation device described in or inferred by this disclosure and/or using such a fixation device once implanted.
  • FIG. 11 illustrates a flowchart related to a method of manufacturing a fixation device, according to some example embodiments.
  • Applicable fixation devices include but are not limited to any fixation device as shown, described and/or inferred in this disclosure. While certain actions and/or steps are discussed in a particular order, the present disclosure is not so limited and, unless specifically indicated, a method of manufacturing a fixation device as discussed anywhere in this disclosure may include one or more additional steps and/or actions, omit one or more disclosed steps and/or actions, or comprise any combination of such steps and/or actions in any suitable order.
  • Flowchart includes block 1102, which includes providing a flexible member comprising a plurality of woven stands and having a fixed length.
  • flexible member 130 may be provided, including a plurality of woven stands (e.g., 132a-b, 134a-b), flexible member 130 having a fixed length l_2, as previously described.
  • providing the flexible member having the fixed length may include weaving the plurality of stands (e.g., 132a-b, 134a,b) such that a first subset of the strands passing in a first relative direction are interlaced with a second subset of the strands passing in a second relative direction that is substantially different than the first relative direction (e.g., 90°).
  • Flowchart includes block 1104, which includes fixedly coupling a first end of the flexible member to a rigid anchor portion that is configured to be directly rotated and driven distally into a first bone or bone portion of a patient.
  • a first end of flexible member 130 may be fixedly coupled to anchor portion 111 , 611 , which is configured to be directly rotated and driven distally into a first bone or bone portion of a patient (e.g., tibia 920 in FIG. 9), as described anywhere in this disclosure.
  • Flowchart includes block 1106, which includes fixedly coupling a second end of the flexible member to a rigid cap portion that is configured to be indirectly rotated under a torque provided by the rigid anchor portion and transferred through the flexible member when the rigid cap portion is held in at least a first amount of longitudinal tension against at least one of a bone plate and a second bone or bone portion of the patient.
  • a second end of flexible member 130 may be fixedly coupled to cap portion 120, 420, 520, which is configured to be indirectly rotated under a torque provided by anchor portion 110, 610 and transferred through flexible member 130 when cap portion 110, 610 is held in at least a first amount of longitudinal tension against at least one of bone plate 900 and a second bone or bone portion of the patient (e.g., fibula 910 of FIG. 9).
  • Such a method of manufacture may include any other step of providing, fabricating, manufacturing, coupling, fixing or any other suitable action for manufacturing any feature or component of any fixation device described in or inferred by this disclosure.
  • a specific method of measuring the characteristic or property may be defined herein as well.
  • the measurement method should be interpreted as the method of measurement that would most likely be adopted by one of ordinary skill in the art given the description and context of the characteristic or property.
  • the value or range of values should be interpreted as being met regardless of which method of measurement is chosen.
  • the methods disclosed herein comprise one or more steps or actions for achieving the described method.
  • the method steps and/or actions may be interchanged with one another without departing from the scope of the claims.
  • the order and/or use of specific steps and/or actions may be modified without departing from the scope of the claims.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Un dispositif de fixation semi-rigide (100) comprend une partie d'ancrage rigide (110) configurée pour être directement mise en rotation et entraînée de manière distale dans un premier os ou une première partie d'os d'un patient. Le dispositif comprend une partie capuchon rigide (120) configurée pour être maintenue en tension contre au moins l'un d'une plaque osseuse et d'un second os ou d'une seconde partie d'os du patient et tournée de manière indirecte sous un couple fourni par la partie d'ancrage. Le dispositif comprend un élément flexible (130) comprenant une pluralité de brins tissés et ayant une longueur fixe entre des première et seconde extrémités, qui sont respectivement couplées de manière fixe à la partie d'ancrage et à la partie capuchon, de telle sorte qu'un couple fourni par la rotation directe de la partie d'ancrage est transféré à travers l'élément flexible à la partie capuchon lorsque l'élément flexible est maintenu dans au moins une première quantité de tension longitudinale.
PCT/US2022/028325 2021-05-10 2022-05-09 Dispositif semi-rigide pour fixation orthopédique WO2022240742A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP22726892.7A EP4337118A1 (fr) 2021-05-10 2022-05-09 Dispositif semi-rigide pour fixation orthopédique

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163186425P 2021-05-10 2021-05-10
US63/186,425 2021-05-10

Publications (1)

Publication Number Publication Date
WO2022240742A1 true WO2022240742A1 (fr) 2022-11-17

Family

ID=81854494

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/028325 WO2022240742A1 (fr) 2021-05-10 2022-05-09 Dispositif semi-rigide pour fixation orthopédique

Country Status (3)

Country Link
US (1) US20220354557A1 (fr)
EP (1) EP4337118A1 (fr)
WO (1) WO2022240742A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4959064A (en) * 1988-10-07 1990-09-25 Boehringer Mannheim Corporation Dynamic tension bone screw
US20020198527A1 (en) * 2001-06-21 2002-12-26 Helmut Muckter Implantable screw for stabilization of a joint or a bone fracture
US20160038201A1 (en) * 2014-08-11 2016-02-11 Wright Medical Technology, Inc. Flexible screw and methods for syndesmosis repair
US20200146735A1 (en) * 2018-11-08 2020-05-14 Nextremity Solutions, Inc. Bone fixation device and method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4959064A (en) * 1988-10-07 1990-09-25 Boehringer Mannheim Corporation Dynamic tension bone screw
US20020198527A1 (en) * 2001-06-21 2002-12-26 Helmut Muckter Implantable screw for stabilization of a joint or a bone fracture
US20160038201A1 (en) * 2014-08-11 2016-02-11 Wright Medical Technology, Inc. Flexible screw and methods for syndesmosis repair
US20200146735A1 (en) * 2018-11-08 2020-05-14 Nextremity Solutions, Inc. Bone fixation device and method

Also Published As

Publication number Publication date
US20220354557A1 (en) 2022-11-10
EP4337118A1 (fr) 2024-03-20

Similar Documents

Publication Publication Date Title
US11896475B2 (en) Implant having adjustable filament coils
US20230000484A1 (en) Method and apparatus for coupling soft tissue to a bone
US11786236B2 (en) Method and apparatus for coupling anatomical features
US10898178B2 (en) Implant having adjustable filament coils
US7625395B2 (en) Implantable screw for stabilization of a joint or a bone fracture
US7678138B2 (en) Two piece cross-pin graft fixation
US20140324101A1 (en) Method And Apparatus For Coupling Anatomical Features
US20120095470A1 (en) Method and Apparatus for Coupling Soft Tissue to a Bone
EP3813685A1 (fr) Ensemble d'ancrage sans noed et ses procédés associés
US10722344B2 (en) Adjustable fixation device
US20180153601A1 (en) Surgical procedure
US20220354557A1 (en) Semi-rigid device for orthopedic fixation
US20230172602A1 (en) Method and apparatus for coupling soft tissue to a bone
US20230389916A1 (en) Method and apparatus for coupling anatomical features
WO2023064346A2 (fr) Dispositifs orthopédiques, systèmes et procédés d'utilisation

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22726892

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2022726892

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2022726892

Country of ref document: EP

Effective date: 20231211